FDA Inspection 1015463 — NYU Langone Health, Transplantation & Cellular Therapy
The FDA completed an inspection of NYU Langone Health, Transplantation & Cellular Therapy on May 18, 2017 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 18, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 87 | 21 CFR 606.100(b)(8) | Methods for pre-transfusion testing |